跳至主要内容
临床试验/NCT05330442
NCT05330442进行中(未招募)不适用

Delivering Written Exposure Therapy for PTSD in Underserved Primary Care Settings

RAND10 个研究点 分布在 1 个国家目标入组 720 人开始时间: 2022年4月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
RAND
入组人数
720
试验地点
10
主要终点
PTSD Checklist, version 5 (PCL-5)

研究概览

简要总结

Posttraumatic stress disorder (PTSD) is a significant problem among underserved populations who receive care in community health centers. Several evidence-based psychotherapies for PTSD are not practical given the time and resources required for these approaches. This research will examine whether Written Exposure Therapy (WET), a brief and well-tolerated therapy approach, delivered within collaborative primary care is effective and can be implemented successfully within a collaborative care (CC) intervention. The primary aims of the proposed study are to evaluate the effectiveness and implementation of delivering WET into CoCM to improve the management of PTSD among underserved primary care patients in Federally Qualified Health Centers (FQHCs).

详细描述

Posttraumatic stress disorder (PTSD) results in substantial costs to society is highly prevalent among adults. Importantly, the prevalence PTSD within primary care settings is even higher than the general population as primary care is the setting to which individuals with PTSD most often present. Evidence-based psychotherapies (EBPs) for PTSD are available but dissemination within real world settings is fraught with challenges because these therapies require 10-15, lengthy treatment sessions and extensive therapist training to implement, and these treatments are not feasible within primary care settings given the limited time resources. Consequently, there are multiple barriers to accessing EBPs for PTSD. Efforts to integrate mental health services within primary care for PTSD though collaborative care management (CoCM) interventions are rapidly expanding and have been shown to be effective in the treatment of depression and anxiety. However, the evidence for PTSD is limited due to the time intensive nature of the PTSD therapy approaches that have been examined. An efficient PTSD treatment approach is needed to address the treatment needs of individuals with PTSD presenting to primary care. Written exposure therapy (WET) is a brief EBP that provides an alternative to more intensive EBPs. Recent studies of WET have yielded positive outcomes and have shown it to be non-inferior when directly compared to more time intensive PTSD EBPs, but WET has not yet been examined within the primary care environment. The primary aims of the proposed study are to evaluate the effectiveness and implementation of delivering WET into CoCM to improve the management of PTSD among underserved primary care patients in Federally Qualified Health Centers (FQHCs). The pragmatic cluster-randomized study will use a hybrid effectiveness-implementation design. Twelve FQHCs will be randomized to either CoCM plus WET (CoCM+WET) or CoCM alone and 60 patients within each FQHC will be screened for eligibility. The investigators will use the RE-AIM framework (for Reach, Efficacy/Effectiveness, Adoption, Implementation, & Maintenance) to evaluate the effectiveness and implementation process of the CoCM+WET intervention using mixed methods. To examine effectiveness and potential mediators and moderators of the intervention, the investigators will administer assessments at baseline, 3- and 12-month follow-up. To assess implementation, the investigators will use clinic process data and clinic staff interviews pre- and post-intervention. This study has the potential to substantially impact practice and public health by validating the effectiveness and feasibility of delivering a brief trauma-focused EBP embedded within CoCM in primary care to improve PTSD outcomes for underserved patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcomes assessors will not know which are patients within health centers are assigned to because they will be independent of the participant recruitment coordinators.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients will be included if they are 18 years of age or older, speak English or Spanish, have a scheduled or walk-in appointment with a participating primary care provider (PCP), have no obvious physical or cognitive impairment that would make them unable to complete the assessment (as indicated by confusion or inability to understand the questions), and consider the FQHC to be their usual source of care.

排除标准

  • •Patients will be excluded if they have active psychosis (as indicated by inability to concentrate, having delusions or hallucinations) or high suicide risk (as indicated by having a current plan or means).

研究组 & 干预措施

CoCM alone

No Intervention

In the CoCM alone arm, participants will have access to treatment as usual from the CM.

CoCM+WET

Experimental

In the CoCM+WET intervention arm, patients will be encouraged to receive WET.

干预措施: Written Exposure Therapy (WET) (Behavioral)

结局指标

主要结局

PTSD Checklist, version 5 (PCL-5)

时间窗: 12-months

PTSD symptoms (total score) and provisional diagnosis anchored to the worst traumatic event

PTSD Checklist, version 5 (PCL-5)

时间窗: baseline

PTSD symptoms (total score) and provisional diagnosis anchored to the worst traumatic event

PTSD Checklist, version 5 (PCL-5)

时间窗: 3-months

PTSD symptoms (total score) and provisional diagnosis anchored to the worst traumatic event

次要结局

  • Veterans RAND 12-item Health Survey (VR-12)(12-months)
  • Patient Health Questionnaire, 8 items (PHQ-8)(12-months)
  • Patient Health Questionnaire, 8 items (PHQ-8)(baseline)
  • Patient Health Questionnaire, 8 items (PHQ-8)(3-months)
  • Veterans RAND 12-item Health Survey (VR-12)(baseline)
  • Veterans RAND 12-item Health Survey (VR-12)(3-months)

研究者

发起方
RAND
申办方类型
Other
责任方
Sponsor

研究点 (10)

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